FIBRINOGEN CALIBRATOR KIT


Device Classification Name

fibrinogen standard

510(k) Number K072304
Device Name FIBRINOGEN CALIBRATOR KIT
Applicant
DADE BEHRING, INC.
p.o. box 6101; ms 514
glasgow bldg. 500
newark, 
DE 
19714 -6101

Applicant Contact radames riesgo
Correspondent
DADE BEHRING, INC.
p.o. box 6101; ms 514
glasgow bldg. 500
newark, 
DE 
19714 -6101

Correspodent Contact radames riesgo
Regulation Number 864.7340
Classification Product Code
GFX  
Date Received 08/17/2007
Decision Date 09/19/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No